NCCN Non-Hodgkin s Lymphomas Guidelines V Update Meeting 06/14/10 and 06/15/10

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1 NCCN Non-Hodgkin s Lymphomas Guidelines V Update Meeting 6/14/1 and 6/15/1 CSLL-D Submitted by sanofi-aventis for the inclusion of oral fludarabine for use in first-line CLL and in other NHL subtypes for first-line and second-line. CSLL-D: CLL without del(11q) or del(17p) CVP (cyclophosphamide, vincristine and prednisone) with or without rituximab should not be an option for first-line therapy. Currently, evidence is insufficient to add oral fludarabine as an option in first-line CLL and in other NHL subtypes for first-line and second-line. Based on the noted reference, which indicated there were no significant differences in clinical outcome between chlorambucil and prednisone and CVP in patients with advanced stage CLL, the panel consensus was to remove vincristine from the combination regimen of CVP with or without rituximab. Raphael B, Andersen JW, Silber R, et al. Comparison of chlorambucil and prednisone versus cyclophosphamide, vincristine, and prednisone as initial treatment for chronic lymphocytic leukemia: long-term follow-up of an Eastern Cooperative Oncology Group randomized clinical trial. J Clin Oncol 91;9: removal of the following regimens used as first-line monotherapy for patients without comorbidities. Alemtuzumab Bendamustine Chlorambucil Fludarabine Based on the noted reference, which indicated a survival advantage with the addition of rituximab, the panel consensus was to remove monotherapy with fludarabine, bendamustine, chlorambucil, and alemtuzumab as treatment options. Fischer K, Cramer P, Stilgenbauer S, et al. Bendamustine combined with rituximab (BR) in first-line therapy of advanced CLL: A multicenter phase II trial of the German CLL Study Group (GCLLSG). Blood (ASH Annual Meeting Abstracts), 29;114: Abstract 25. Hallek M, Fingerle-Rowson G, Fink A-M, et al. First-line treatment with fludarabine (F), cyclophosphamide (C), and rituximab (R) (FCR) improves overall survival (OS) in previously untreated patients (pts) with advanced chronic lymphocytic leukemia (CLL): Results of a randomized phase III trial on behalf of an international group of investigators and the German CLL Study Group. Blood (ASH Annual Meeting Abstracts). 29;114:535-. Robak T, Dmoszynska A, Solal-Celigny P, et al. Rituximab Plus Fludarabine and Cyclophosphamide Prolongs Progression-Free Survival Compared With Fludarabine and Cyclophosphamide Alone in Previously Treated Chronic Lymphocytic Leukemia. J Clin Oncol. 21;28:

2 NCCN Non-Hodgkin s Lymphomas Guidelines V Update Meeting 6/14/1 and 6/15/1 inclusion of bendamustine plus rituximab used as first-line chemoimmunotherapy for patients without comorbidities. Based on the noted reference, the panel consensus was to list bendamustine plus rituximab as a firstline chemoimmunotherapy. Fischer K, Cramer P, Stilgenbauer S, et al. Bendamustine combined with rituximab (BR) in first-line therapy of advanced CLL: A multicenter phase II trial of the German CLL Study Group (GCLLSG). Blood (ASH Annual Meeting Abstracts), 29;114: Abstract 25. inclusion of cladribine as first-line monotherapy for age 7 y or younger patients with comorbidities. Based on the noted references, the panel consensus was to list cladribine as first-line monotherapy for age 7 y or younger patients with co-morbidities. Robak T, Bloński JZ, Kasznicki M, et al. Cladribine with or without prednisone in the treatment of previously treated and untreated B-cell chronic lymphocytic leukaemia - updated results of the multicentre study of 378 patients. Br J Haematol 2;18: Robak T, Błasińska-Morawiec M, Błoński JZ, Dmoszyńska A. 2- chlorodeoxyadenosine (cladribine) in the treatment of elderly patients with B-cell chronic lymphocytic leukemia. Leuk Lymphoma 99;34: Internal request the inclusion of alemtuzumab ± rituximab for the treatment of relapsed/refractory therapy for age 7 y with a short response < 2 y. CSLL-D: CLL with del(17p) the inclusion of rituximab with high-dose methylprednisolone (HDMP) for relapsed or refractory disease. Based on the noted reference, the panel consensus was to list alemtuzumab ± rituximab for the treatment of relapsed/refractory therapy age 7 y with a short response < 2 y. Based on the noted reference, the panel consensus was to include ± rituximab with HDMP for patients with relapsed /refractory CLL with del(17p). Faderl S, Thomas DA, O'Brien S, et al. Experience with alemtuzumab plus rituximab in patients with relapsed and refractory lymphoid malignancies. Blood 23;11: Bowen DA, Call TG, Jenkins GD, et al. Methylprednisolone-rituximab is an effective salvage therapy for patients with relapsed chronic lymphocytic leukemia including those with unfavorable cytogenetic features. Leukemia and Lymphoma. 27;48: the inclusion of ± rituximab with bendamustine for relapsed or refractory disease. Based on the noted reference, the panel consensus was to include ± rituximab with bendamustine for patients with relapsed/refractory CLL with del(17p). Fischer K, Stilgenbauer S, Schweighofer CD, et al. Bendamustine in combination with rituximab (BR) for patients with relapsed chronic lymphocytic leukemia (CLL): A multicentre phase II trial of the German CLL Study Group (GCLLSG). ASH Annual Meeting Abstracts. 28;112:33- Submitted by Genzyme Corporation 1. Alemtuzumab ± rituximab was already included in the 1.21 NCCN NHL guidelines

3 NCCN Non-Hodgkin s Lymphomas Guidelines V Update Meeting 6/14/1 and 6/15/1 1. Consider adding alemtuzumab monotherapy as a treatment option for patients with relapsed/ refractory CLL with del(17p) mutation 2. Consider re-evaluating order of alemtuzumab on the list of suggested treatment regimens in patients with first-line CLL with del(17p) based on current clinical data CSLL-D: CLL with del(11q) Panel discussion for the inclusion of suggested treatment regimens for a new algorithm for CLL with del(11q). for this indication. 2. The panel consensus was for alemtuzumab to remain as currently listed. Based on panel consensus, the corresponding treatment options for the new algorithm for CLL with del(11q) were included. Follicular lymphoma FOLL-B: Institutional review comment to change bendamustine plus rituximab to a category 1 recommendation. Based on data in the noted reference, which demonstrated that bendamustine plus rituximab was associated with significantly better response and progression-free survival rates compared to R- CHOP in patients with newly diagnosed follicular, indolent and mantle cell lymphomas, the panel consensus was to change the bendamustine plus rituximab from a category 2A as a category 1 recommendation. Rummel MJ, Niederle N, Maschmeyer G, et al. Bendamustine plus rituximab is superior in Respect of progression free survival and CR rate when compared to CHOP plus rituximab as first-line treatment of patients with advanced follicular, indolent, and mantle cell lymphomas: Final results of a randomized phase III study of the StiL (Study Group Indolent Lymphomas, Germany). Blood (ASH Annual Meeting Abstracts). 29;114:45-. Institutional review comment to change rituximab maintenance as first-line consolidation or extended dosing a category 1 recommendation. Submitted by Genentech to review data for the use of maintenance rituximab for the treatment of follicular lymphoma. Based on data in the noted reference, which demonstrated that rituximab maintenance for 2 years after induction chemoimmunotherapy significantly improves progression-free survival in untreated patients responding to induction therapy, the panel consensus was to change rituximab maintenance from a category 2B to a category 1 recommendation. Salles GA, Seymour JF, Feugier P, et al. Rituximab maintenance for 2 years in patients with untreated high tumor burden follicular lymphoma after response to immunochemotherapy. J Clin Oncol (Meeting Abstracts) 21;28:84.

4 NCCN Non-Hodgkin s Lymphomas Guidelines V Update Meeting 6/14/1 and 6/15/1 Marginal Zone Lymphomas Submitted by Millennium to include bortezomib in marginal zone lymphomas. Mantle Cell Lymphoma MANT-A: the inclusion of RCVP (rituximab, cyclophosphamide, vincristine, prednisone) as a less aggressive induction therapy. The panel consensus was that evidence is insufficient to add bortezomib as an option in marginal zone lymphomas. Based on the data in the noted references, the panel consensus was to list CVP ± rituximab as one of the options for less aggressive induction therapy. de Vos S, Goy A, Dakhil SR, et al. Multicenter randomized phase II study of weekly or twiceweekly bortezomib plus rituximab in patients with relapsed or refractory follicular or marginal-zone B-cell lymphoma. J Clin Oncol. 29;27: Di Bella N, Taetle R, Kolibaba K, et al. Results of a phase 2 study of bortezomib in patients with relapsed or refractory indolent lymphoma. Blood. 21;115: Teodorovic I, Pittaluga S, Kluin-Nelemans J, et al. Efficacy of four different regimens in 64 mantle-cell lymphoma cases: clinicopathologic comparison with 498 other non-hodgkin's lymphoma subtypes. European Organization for the Research and Treatment of Cancer Lymphoma Cooperative Group. J Clin Oncol. 95;13: Martin P, Chadburn A, Christos P, et al. Intensive treatment strategies may not provide superior outcomes in mantle cell lymphoma: overall survival exceeding 7 years with standard therapies. Ann Oncol. 28;: inclusion of CALGB regimen (rituximab combined with methotrexate and augmented CHOP) as an option for aggressive therapy. Based on data in the noted reference, which reported that rituximab combined with methotrexate and augmented CHOP followed by HDT/ASCT is safe and effective in patients with newly diagnosed MCL, the panel consensus was to list the CALGB 5999 regimen as one of the options for aggressive induction therapy. Damon LE, Johnson JL, Niedzwiecki D, et al. Immunochemotherapy and Autologous Stem-Cell Transplantation for Untreated Patients With Mantle-Cell Lymphoma: CALGB J Clin Oncol. 29;27:

5 NCCN Non-Hodgkin s Lymphomas Guidelines V Update Meeting 6/14/1 and 6/15/1 inclusion of sequential RCHOP/RICE (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)/ (rituximab, ifosfamide, carboplatin, etoposide). Based on data in the noted reference, the panel consensus was to list sequential RCHOP/RICE as one of the options for aggressive induction therapy Schaffel R, Hedvat CV, Teruya-Feldstein J, et al. Prognostic impact of proliferative index determined by quantitative image analysis and the International Prognostic Index in patients with mantle cell lymphoma. Ann Oncol 21;21: removal of thalidomide plus rituximab and temsirolimus as options for second-line therapy. Panel consensus was to remove thalidomide plus rituximab as a treatment option as it not an effective regimen and is no longer being used and to remove temsirolimus as an option for second-line therapy as the durability of benefit is small. Panel discussion comment to add rituximab to lenalidomide as an option for second-line therapy Panel discussion comment to change cladribine ± rituximab to cladribine + rituximab as an option for second-line therapy Based on data in the noted reference, the panel consensus was to list ± rituximab with lenalidomide as a second-line therapy option. Based on the data in the noted reference, which indicate that the addition of rituximab improves the duration of response, the panel consensus was to list + rituximab with cladribine. Wang L, Fayad L, Hagemeister FB, et al. A phase I/II study of lenalidomide in combination with rituximab in relapsed/refractory mantle cell lymphoma. ASH Annual Meeting Abstracts. 29;114:27 Inwards DJ, Fishkin PA, Hillman DW, et al. Longterm results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone ( ) or 2-CDA and rituximab (N189) in the North Central Cancer Treatment Group. Cancer 28;113: Diffuse Large B-Cell Lymphoma

6 NCCN Non-Hodgkin s Lymphomas Guidelines V Update Meeting 6/14/1 and 6/15/1 BCEL-C the inclusion of RCEOP (rituximab, cyclophosphamide, etoposide, vincristine, prednisone) as first-line therapy for patients with poor left ventricular function and as second-line therapy in noncandidates for transplant. the inclusion of RGemOX (rituximab, gemcitabine, oxaliplatin) as an option for second-line therapy in noncandidates for transplant. Based on data in the noted reference, the panel consensus was to list RCEOP as a first-line therapy for patients with poor left ventricular function and CEOP ± rituximab as second-line therapy in non-candidates for transplant. Based on data in the noted references, the panel consensus was to list GemOx ± rituximab as secondline therapy in non-candidates for transplant. Moccia et al. R-CHOP with etoposide substituted for doxorubicin (R-CEOP): Excellent outcome in diffuse large B cell lymphoma for patients with a contraindication to anthracyclines. 29 ASH Annual Meeting. Abstract 48. Corazzelli G, Capobianco G, Arcamone M, et al. Long-term results of gemcitabine plus oxaliplatin with and without rituximab as salvage treatment for transplant-ineligible patients with refractory/relapsing B-cell lymphoma. Cancer Chemother Pharmacol. 29;64: El Gnaoui T, Dupuis J, Belhadj K, et al. Rituximab, gemcitabine and oxaliplatin: an effective salvage regimen for patients with relapsed or refractory B-cell lymphoma not candidates for high-dose therapy. Ann Oncol. 27;18: Panel discussion comment for inclusion of GDP (gemcitabine, dexamethasone, cisplatin) ± rituximab as an option for secondline therapy in non-candidates for transplant. Based on data in the noted reference, the panel consensus was to list GDP ± rituximab as an option for second-line therapy in non-candidates for transplant. Crump M, Baetz T, Couban S, et al. Gemcitabine, dexamethasone, and cisplatin in patients with recurrent or refractory aggressive histology B-cell non-hodgkin lymphoma: a Phase II study by the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG). Cancer 24;11: Panel discussion comment to add ± rituximab to lenalidomide as an option second-line therapy. Based on panel consensus, ± rituximab was added to lenalidomide as an option for second-line therapy. Submitted by Spectrum Pharmaceuticals for yttrium-9 ibritumomab tiuxetan be added as therapeutic regimen for the treatment of DLBCL. The panel consensus was that current evidence is insufficient to add yttrium-9 ibritumomab tiuxetan as a treatment option in DLBCL. Morschhauser F, Illidge T, Huglo D, et al. Efficacy and safety of yttrium-9 ibritumomab tiuxetan in patients with relapsed or refractory diffuse large B- cell lymphoma not appropriate for autologous stemcell transplantation. Blood 27;11:54-58.

7 NCCN Non-Hodgkin s Lymphomas Guidelines V Update Meeting 6/14/1 and 6/15/1 Burkitt Lymphoma BURK-A inclusion of the following regimens for second-line therapy- REPOCH (rituximab etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) RGDP (rituximab, gemcitabine, dexamethasone, cisplatin) High-dose cytarabine RIVAC (rituximab, ifosfamide, cytarabine, etoposide and intrathecal methotrexate) Based on panel consensus, REPOCH, RGDP, highdose cytarabine, and RIVAC were added as options for second-line therapy for select patients with a reasonable remission. Primary Cutaneous B-cell Lymphomas CUTB-3 and 4 inclusion of ± rituximab with chlorambucil. Based on data in the noted reference, the panel consensus was to list ± rituximab with chlorambucil. Heinzerling LM, Urbanek M, Funk JO, et al. Reduction of tumor burden and stabilization of disease by systemic therapy with anti-cd2 antibody (rituximab) in patients with primary cutaneous B-cell lymphoma. Cancer 2;89:

8 NCCN Non-Hodgkin s Lymphomas Guidelines V Update Meeting 6/14/1 and 6/15/1 Peripheral T-Cell Lymphoma TCEL-B inclusion of the following regimens as other first-line therapy regimens that can be used for PTCL. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) every 2 or 3 weeks CHOEP (cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone) CHOP followed by ICE (ifosfamide, carboplatin, etoposide) CHOP followed by IVE (ifosfamide, etoposide and epirubicin) alternating with intermediate dose methotrexate [New Castle Regimen] HyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with high-dose methotrexate and cytarabine Based on data in the cited references and discussion, the panel consensus was to include other anthracycline-based regimens which have been used for the treatment of patients PTCL. CHOP or CHOP-14 with or without etoposide: Pfreundschuh M, Trümper L, Kloess M, Schmits R, et al. German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood 24;14: Pfreundschuh M, Trümper L, Kloess M, Schmits R, et al. German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of elderly patients with aggressive lymphomas: results of the NHL- B2 trial of the DSHNHL. Blood 24;14: CHOP followed by ICE: Horwitz S, Moskowitz C, Kewalramani T, et al. Second- Line Therapy with ICE Followed by High Dose Therapy and Autologous Stem Cell Transplantation for Relapsed/Refractory Peripheral T-Cell Lymphomas: Minimal Benefit When Analyzed by Intent To Treat. ASH Annual Meeting Abstracts. 25;16: CHOP followed by IVE: Sieniawski M, Lennard J, Millar C, et al. Aggressive Primary Chemotherapy Plus Autologous Stem Cell Transplantation Improves Outcome for Peripheral T Cell Lymphomas Compared with CHOP-Like Regimens. ASH Annual Meeting Abstracts. 29;114:166-. Hyper CVAD: Escalon MP, Liu NS, Yang Y, et al. Prognostic factors and treatment of patients with T-cell non-hodgkin lymphoma: The M. D. Anderson Cancer Center experience. Cancer. 25;13: Pozadzides JV et al. Prognosis and treatment of patients with peripheral T-cell lymphoma: The M. D. Anderson Cancer Center experience. 21 ASCO Annual Meeting Abstract 851.

9 NCCN Non-Hodgkin s Lymphomas Guidelines V Update Meeting 6/14/1 and 6/15/1 Mycosis Fungoides/Sezary Syndrome MFSS-A inclusion of pralatrexate as a systemic therapy option for transformed MF. Submitted by Allos to include pralatrexate as a treatment option for transformed MF. Panel discussion comment for inclusion of additional systemic therapies for transformed MF: Liposomal doxorubicin Gemcitabine Denileukin diftitox Romidepsin Low or standard pralatrexate Based on the noted references and panel discussion, the panel consensus was to list pralatrexate as an option for second-line systemic therapy for relapsed or refractory MFSS and aggressive large cell transformed MF. Based on the noted references and panel discussion, the panel consensus was to list these agents as systemic therapies for relapsed or refractory MFSS and aggressive large cell transformed MF. O'Connor O, Pro B, Pinter-Brown L, et al. PROPEL: Results of the pivotal, multicenter, phase II study of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). J Clin Oncol (Meeting Abstracts). 29;27:8561. Horwitz et al. Pralatrexate is active in cutaneous T- cell lymphoma (CTCL): Results of a multicenter, dose-finding trial. 29 ASH Annual Meeting. Abstract 9. Low dose Pralatrexate Horwitz SM, Duvic M, Kim Y, et al. Pralatrexate is active in cutaneous T-cell lymphoma (CTCL): Results of a multicenter, dose-finding trial. ASH Annual Meeting Abstracts. 29;114:91. Liposomal doxorubicin Quereux G, Marques S, Nguyen J-M, et al. Prospective multicenter study of pegylated liposomal doxorubicin treatment in patients with advanced or refractory mycosis fungoides or Sezary syndrome. Arch Dermatol 28;144: Gemcitabine Awar O, Duvic M. Treatment of transformed mycosis fungoides with intermittent low-dose gemcitabine. Oncology 27;73: Pralatrexate O'Connor O, Pro B, Pinter-Brown L, et al. PROPEL: Results of the pivotal, multicenter, phase II study of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). ASCO Meeting Abstracts. 29;27:8561. Romidepsin Piekarz R, Wright J, Frye R, et al. Final results of a phase 2 NCI multicenter study of romidepsin in patients with relapsed peripheral T-cell lymphoma (PTCL). ASH Annual Meeting Abstracts. 29;114: Denileukin diftitox Talpur R, Jones DM, Alencar AJ, et al. CD25 expression is correlated with histological grade and response to denileukin diftitox in cutaneous T-cell lymphoma. J Invest Dermatol 26;126:

10 NCCN Non-Hodgkin s Lymphomas Guidelines V Update Meeting 6/14/1 and 6/15/1 Extranodal NK/T-cell Lymphoma, nasal type NKTL-B inclusion of suggested treatment regimens for a new guideline extranodal NK/T-cell lymphoma, nasal type Combined modality therapy: o CCRT (radiation and cisplatin) followed by 3 cycles of VIPD (etoposide, ifosfamide, cisplatin, and dexamethasone) o CCRT (radiation 5 Gy and 3 courses of DeVIC [dexamethasone, etoposide, ifosfamide, and carboplatin]) Combination chemotherapy regimen: o SMILE regimen (steroid [dexamethasone], methotrexate, ifosfamide, L- asparaginase, and etoposide) Based on panel consensus and noted references, the corresponding treatment options for the new guideline for extranodal NK/T-cell lymphoma, nasal type, were added. Combined modality therapy Yamaguchi M TK, Oguchi M, Isobe Y, et al, Japan Clinical Oncology Group Lymphoma Study Group (JCOG-LSG) Phase I/II study of concurrent chemoradiotherapy for localized nasal NK/T-cell lymphoma: Final results of JCOG211. J Clin Oncol (Meeting Abstract). 29;27:8549. Kim SJ, Kim K, Kim BS, et al. Phase II trial of concurrent radiation and weekly cisplatin followed by VIPD chemotherapy in newly diagnosed, stage IE to IIE, nasal, extranodal NK/T-cell lymphoma: Consortium for Improving Survival of Lymphoma study. J Clin Oncol 29;27: SMILE regimen Jaccard A, Coppo P, Morschhauser F, et al. A prospective phase II trial of an L-asparaginase containing regimen in patients with refractory or relapsing extra nodal NK/T-cell lymphoma. ASH Annual Meeting Abstracts. 28;112:79. Yamaguchi M KY, Maeda Y, Hashimoto C, et al and The NK-Cell Tumor Study Group Phase II study of SMILE chemotherapy for newlydiagnosed stage IV, relapsed or refractory extranodal NK/T-cell lymphoma, nasal type: NKTSG study. J Clin Oncol (Meeting Abstract). 21;28:844.

11 NCCN Non-Hodgkin s Lymphomas Guidelines V Update Meeting 6/14/1 and 6/15/1 Post-Transplant Lymphoproliferative Disorder PTLD-A inclusion of suggested treatment regimens for a new guideline post-transplant lymphoproliferative disorder RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) RCHOEP (rituximab, ritcyclophosphamide, doxorubicin, vincristine, prednisone, etoposide) RCVP rituximab, cyclophosphamide, vincristine, prednisone) (for frail patients who cannot tolerate anthracycline) Rituximab Based on panel consensus and noted references, the corresponding treatment regimens (RCHOP, RCHOEP, RCVP, rituximab) were added as suggested treatment regimens for the new guideline for PTLD. Choquet S, Trappe R, Leblond V, et al. CHOP-21 for the treatment of post-transplant lymphoproliferative disorders (PTLD) following solid organ transplantation. Haematologica 27;92: Oertel SHK, Verschuuren E, Reinke P, et al. Effect of anti-cd 2 antibody rituximab in patients with post-transplant lymphoproliferative disorder (PTLD). Choquet S, Leblond V, Herbrecht R, et al. Efficacy and safety of rituximab in B-cell posttransplantation lymphoproliferative disorders: results of a prospective multicenter phase 2 study. Blood 26;17: Trappe R, Hinrichs C, Appel U, et al. Treatment of PTLD with rituximab and CHOP reduces the risk of renal graft impairment after reduction of immunosuppression. Am J Transplant 29;9: Orjuela M, Gross TG, Cheung Y-K, et al. A pilot study of chemoimmunotherapy (cyclophosphamide, prednisone, and rituximab) in patients with post-transplant lymphoproliferative disorder following solid organ transplantation. Clin Cancer Res 23;9:52.

12 NCCN Non-Hodgkin s Lymphomas Guidelines V Update Meeting 6/14/1 and 6/15/1 NHODG-B: Institutional review comment to recommend a single dose of rasburicase in patients with aggressive lymphoma and an elevated uric acid prior to initiating chemotherapy. Submitted by sanofi-aventis for the addition of prophylactic rasburicase use in high or potential risk for TLS patients. Based on the noted reference, the panel consensus was to expand the use of rasburicase for patients who are at high-risk of developing TLS. Cortes J, Seiter K, Maziarz RT, et al. Superiority of rasburicase versus allopurinol on serum uric acid control in adult patients with hematological malignancies at risk of developing tumor lysis syndrome: Results of a randomized comparative phase III study. ASH Annual Meeting Abstracts. 28;112:9-.